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Completed

NCT Number: NCT01443026

The Effects of Lycopene on High Risk Prostatic Tissue

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

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Key information

Conditions

Intraepithelial Prostatic Neoplasia Carcinoma Carcinoma in Situ Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Intraepithelial Neoplasia Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Jesse Brown VA Medical Center, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
  • Have an AUA symptom score <=25 at time of registration.
  • Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
  • Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
  • Be willing to limit intake of lycopene-containing foods while on study
  • Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
  • Be ambulatory, capable of self-care and able to carry out light or sedentary work
  • Have a dietary fat intake of 23-48% of calories
  • Participant's physician recommends repeat biopsy 4-6 months after randomization

Exclusion criteria

  • No repeat biopsy planned
  • Not willing to change diet
  • Have a diagnosis of prostate cancer

Treatment and study plan

Lycopene 30mg

Drug

Lycopene 30 mg.

Other names: Lyco-Mato

Placebo

Drug

Placebo

Other names: Sugar Pill

Primary outcomes

  1. Tissue Biomarkers

    Time frame: baseline and 6 months

    We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.

  2. Changes in Serum Biomarkers

    Time frame: baseline and 6 months

    Change in serum lycopene, umol/L

Secondary outcomes

  1. Changes in Nuclear Morphometry

    Time frame: baseline and 6 months

    We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 29, 2011
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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